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An Intervention Study To Improve Human PapillomaVirus ( HPV) Immunization in Haitian and African American Girls (HPV)

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ClinicalTrials.gov Identifier: NCT01254669
Recruitment Status : Completed
First Posted : December 6, 2010
Results First Posted : October 24, 2014
Last Update Posted : May 19, 2017
Sponsor:
Information provided by (Responsible Party):
Natalie Pierre-Joseph, Boston Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Cervical Cancer
Intervention Behavioral: BNI-brief Negotiated Interview
Enrollment 200
Recruitment Details We recruited 100 English- and 100 Haitian Creole-speaking mothers of adolescent girls between April 2011 and September 2013 at the medical clinic ( pediatrics and adolescent clinic). Of 1,703 mothers approached during the study period,1,201 were ineligible. Of the 502 eligible, 302 declined and 200 (40%) were recruited &consented to pilot trial.
Pre-assignment Details Following participant enrollment, but prior to group assignment, no significant event occurred. However, in our study after being randomized, participants provided demographic data. During data collection, one participants was excluded/self-withdrew from the trial for fear that demographic data may affect her immigration status/not documented.
Arm/Group Title Standard of Care Brief Negotiated Inteview (BNI) Intervention
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A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve Human Papilloma Virus (HPV) vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.

Mothers assigned to the Control Group received the low-literacy, standard-practice, HPV vaccine information sheet usually given to all patients prior to vaccination. Control mothers met once with the research assistant to collect demographic characteristics, HPV knowledge, and vaccine status of the daughter on the day of visit. No Brief Negotiated Intervention (BNI) counseling was provided.

A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.

One hundred mothers received intervention (n=50 Haitian, 50 African-American). Four Haitian mothers did not receive intervention because (i) One was called to see the clinical provider during the intervention and did not return (n=1), and (ii) time constraints (n=2) and one dropped out for fear information from study will affect her immigration status

Period Title: Overall Study
Started 100 100
Completed 97 96
Not Completed 3 4
Reason Not Completed
Withdrawal by Subject             0             1
time constraint             2             2
called to clinic during intervention             1             1
Arm/Group Title Standard of Care BNI/Intervention Total
Hide Arm/Group Description

A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.

Of the 100 women in the Control Group (n=50 Haitian, 50 African-American), three African-American mothers did not complete Control Group activities because they did not complete the survey. Reasons for initial dropout/decline to participate included being too busy, not interested, time constraints, and daughter not sexually active upon hearing study has to do with HPV vaccine.

One hundred mothers received intervention (n=50 Haitian, 50 African-American). Four Haitian mothers did not receive intervention because (i) One was called to see the clinical provider during the intervention and did not return (n=1), and (ii) time constraints (n=2), one for immigration status . Total of all reporting groups
Overall Number of Baseline Participants 100 100 200
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
age Number Analyzed 100 participants 100 participants 200 participants
41  (7) 40  (9) 41  (8)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
100
 100.0%
100
 100.0%
200
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
Female
100
 100.0%
100
 100.0%
200
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
100
 100.0%
100
 100.0%
200
 100.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
100
 100.0%
100
 100.0%
200
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 100 participants 100 participants 200 participants
100 100 200
knowledge of HPV vaccine   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 100 participants 100 participants 200 participants
5  (4) 6  (4) 5  (4)
[1]
Measure Description: Assessment of HPV knowledge range from 0 (minimal) to 12 ( maximal knowledge)
1.Primary Outcome
Title The Receipt of the First HPV Vaccination
Hide Description Receipt of the first HPV vaccination among adolescent daughters of the participants
Time Frame within 1 month of randomization
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined based on number of participants enrolled and who answered questions of interest.
Arm/Group Title Standard of Care BNI/Intervention
Hide Arm/Group Description:

A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.

Of the 100 women in the Control Group (n=50 Haitian, 50 African-American), received the standard of care handout given to patients on the vaccine they will be getting that day. three African-American mothers did not complete Control Group activities because they did not complete the survey. Reasons for initial dropout/decline to participate included being too busy, not interested, time constraints, and daughter not sexually active upon hearing study has to do with HPV vaccine.

Intervention was administered to 100 African-American and Haitian mothers over 10-20 minutes prior to seeing the health provider if the daughter had never received the HPV vaccine, or after seeing the health provider if the daughter did not received the vaccine during the visit.
Overall Number of Participants Analyzed 97 96
Measure Type: Number
Unit of Measure: percentage of participants
51 56
2.Secondary Outcome
Title The Secondary Outcome Will be Maternal Knowledge About HPV Vaccine.
Hide Description post-educational intervention assessment of HPV knowledge ranges from 0 (minimal knowledge) to 12 (maximal knowledge)
Time Frame 1 hour after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined based on the total enrolled and who responded to knowledge questions
Arm/Group Title BNI Post-educational Intervention Group Control Group
Hide Arm/Group Description:

A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.

Post-educational interventional assessment of HPV knowledge ranges from 0(minimal knowledge) to 12 (maximal knowledge)

Did not receive any BNI intervention on the pre and post measure
Overall Number of Participants Analyzed 99 96
Mean (Standard Deviation)
Unit of Measure: units on a scale
10  (2) 5  (2)
Time Frame 1 year- no adverse event over
Adverse Event Reporting Description no adverse event
 
Arm/Group Title Standard of Care BNI/Intervention
Hide Arm/Group Description

A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.

Of the 100 women in the Control Group (n=50 Haitian, 50 African-American), three African-American mothers did not complete Control Group activities because they did not complete the survey. Reasons for initial dropout/decline to participate included being too busy, not interested, time constraints, and daughter not sexually active upon hearing study has to do with HPV vaccine.

One hundred mothers received intervention (n=50 Haitian, 50 African-American). . Four Haitian mothers did not receive intervention because (i) One was called to see the clinical provider during the intervention and did not return (n=1), and (ii) time constraints (n=2), one due to fear of information affecting immigration status.
All-Cause Mortality
Standard of Care BNI/Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Standard of Care BNI/Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)   0/100 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard of Care BNI/Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)   0/100 (0.00%) 
Limitations:small sample,Enrolling only mothers, of daughters who are African-American and Haitians lead to longer recruitment time/non-generalizable data. Future studies should include heterogeneous ethnicities,fathers, sons, and any legal guardian.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Natalie Joseph
Organization: Boston Medical Center
Phone: 1-617-414-5202
EMail: napierre@bu.edu
Layout table for additonal information
Responsible Party: Natalie Pierre-Joseph, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01254669     History of Changes
Other Study ID Numbers: H26306
First Submitted: July 28, 2010
First Posted: December 6, 2010
Results First Submitted: July 31, 2014
Results First Posted: October 24, 2014
Last Update Posted: May 19, 2017